E-STATIS Advantage 40 System / Système

E-STATIS Advantage 40 System / Système Operating Instructions Manuel de l opérateur Gebrauchsanweisung CAUTION: In the U.S.A.: Federal law restricts this device to sale by or on the order of a dentist. E-STATIS Advantage 40 - System Copyright 2010 SciCan. All rights reserved. www.scican.com Doc. No. 2.000.9476 Rev. 2013-07

Table of Contents en 1 Important Information... 3 Packing List... 3 Intended Use... 3 Disposal... 4 Service... 4 Operating Mode... 4 Safety Precautions... 4 Applied Symbols... 6 Exclusion of Liability... 6 2 Cleaning and Maintenance... 7 Cleaning... 7 Maintenance... 7 3 Installation and Commissioning... 8 Location... 8 Connection... 8 Connect Power Supply... 8 Connect Control Unit... 9 Connect Medical Device... 9 Calibrate Foot Control... 10 4 Operation... 11 General Operation... 11 Mode - Interpretation... 13 Display Symbols... 14 Settings: Preparation Mode P1 to P3... 15 Settings: Endodontic Mode E1 to E5... 16 Settings: Set-up Menu... 17 5 Troubleshooting... 19 6 Information on Electromagnetic Compatibility... 20 7 Specifications... 22 Control Unit... 22 Power Supply... 22 Media Supply Data to Control Unit... 22 Recommended Settings... 23 Ambient Conditions... 23 Type Label... 23 8 Spare Parts... 24 9 Guarantee... 25 E-STATIS is a trademark of SciCan Ltd. All other trademarks referred to in this manual are the property of their respective owners. SciCan Ltd. 1440 Don Mills Road Toronto, ON M3B 3P9, CANADA Phone: +1-416-445-1600 Fax: +1-416-445-2727 Toll free: +1-800-667-7733 E-mail: SciCan Medtech AG Manufactured by: Alpenstrasse 16 6300 Zug, SWITZERLAND SciCan GmbH Phone: +41-41-727-70-27 Wangener Strasse 78 Fax: +41-41-727-70-29 techservice.ca@scican.com 88299 Leutkirch SciCan Inc. GERMANY 701 Technology Drive Phone: +49-7561-98343-0 Canonsburg, PA 15317, USA Fax: +49-7561-98343-699 0297 Phone: +1-724-820-1600 Fax: +1-724-820-1479 E-STATIS Advantage 40

1 Important Information 1 Important Information Dear user, We hope that you will enjoy using your new quality product. In order to ensure that you can work in a trouble-free, economical and safe manner, please comply with the instructions below. Packing List E-STATIS Advantage system unit E-STATIS SLM motor Operating instructions Power supply 100-240 V AC Power supply cord set The operating instructions should be read by the user before starting up the unit for the first time in order to avoid incorrect operation or damage. Duplication and/or distribution of these operating instructions requires the manufacturer s prior consent. All specifications, information and properties of the product described in these operating instructions correspond to the status upon going to press. Modifications and improvements to the product as a result of new technical developments are possible. This does not imply any right to retrofitting of existing units. The manufacturer assumes no responsibility for damage arising through: External influences (poor quality of the media or faulty installation) Use of incorrect information Improper use Improperly performed repairs Repair and maintenance work - apart from the activities described in these operating instructions - may be performed only by qualified technical staff. In the event of modifications by third parties, existing medical device licences become null and void. Only use original parts and spare parts. Intended Use This medical device is: Only intended for dental treatment. Any other type of use or alteration to the product is impermissible and can be hazardous. Intended for the following use: Removal of carious material, cavities and crown preparations, removal of fillings, processing of tooth and restoration surfaces and endodontic treatment. A medical device according to relevant national statutory regulations. This medical product: Includes a low-voltage electric dental motor in accordance with ISO 11498 type 2 Is not approved for use in areas with an increased risk of explosion. (It is not suitable to use the dental unit in an atmosphere of flammable mixtures. Definition (intended purpose) Meaning Main function Dental treatment for preparation and endodontic Use For dental treatment of crowns and roots Main functional specifications Mains powered additional component for dentist s unit Duration of use Approx. 30-40 minutes with individual interruptions per day Population: all patients (all age-groups) Page 3 E-STATIS Advantage 40

1 Important Information According to these provisions, the medical device is only to be used by an experienced user for the described application in accordance with: The applicable health and safety regulations The applicable accident prevention regulations The operating instructions According to these regulations, the user is required to: Only use equipment which is free of faults and works properly Only use the equipment for the proper purpose Protect himself, the patient and third parties from danger Avoid contamination from the product Improper handling of handpieces: Incorrect handling can result in injury to persons Follow the separate user instructions for the attachments. Target group: This document is for dentists and office personnel. Disposal Consumables: The wastes incurred are to be recycled or disposed of in a way that is harmless for human beings and the environment; in doing so, the national valid regulations are to be observed. Disposal of equipment and accessories at the end of their service lives: Europe: this product is subject to the EC Directive 2002/96/EC, known as the European Union s WEEE Directive (Directive on Waste Electrical and Electronic Equipment). Under this directive, waste electrical product must be disposed of according to the local regulations concerning their recovery and safe disposal. Additional information can be obtained from the manufacturer or your dental supplier. Service Note: Send the product every 2 years for a service check. The safety check (STK) according to VDE 0751-1 and the measurement check (MTK) will be carried out during service check. The safety checks in different countries can vary in compliance with country specific regulations and requirements for medical devices. The national valid regulations are to be observed. Operating Mode Note: 30 seconds operating time and 9 minutes interval is the feasible limit load of the motor (full load at maximum speed). In practice, it is realistic for impulse loading to last a number of seconds and intervals to last anywhere between a number of seconds to a number of minutes, with the maximum motor current not usually being reached. This represents the typical procedure for dentists. Safety Precautions Risks from electromagnetic fields (pacemakers): The functions of implanted systems (such as pacemakers) can be influenced by electromagnetic fields. Ask patients before starting treatment and inform them about the risks. Page 4 E-STATIS Advantage 40

1 Important Information Electricity: Electrical shock caused by incorrectly connecting third-party system to the medical device. When installing and operating the medical device with treatment equipment and devices from other manufacturers, observe the provisions in "Protection against electrical shock," "Leakage current," and "Non-grounding the application part" in accordance with IEC 60601-1. Risk from the lack of control equipment: Hazards can arise if control equipment is not available for changing the speed and the direction of rotation. The connected dental treatment unit must have control equipment for changing the speed and direction of rotation. In addition, the accompanying documents must refer to them due to responsibilities arising from safety, reliability and performance. Premature wear and tear; malfunctions caused by improper care and maintenance: Foreshortened product life: Perform proper care and maintenance operations on a regular basis. Malfunctions from electromagnetic fields: The product meets the applicable requirements regarding electromagnetic fields. Given the complex interactions between equipment and cell phones, the product may be influenced by a cell phone that is in use. Do not use cell phones in medical offices, hospitals or laboratories. Turn off electronic devices such as computer storage media, hearing aids etc. during operation. Damaged cord / brittle cord / no ground wire: Electric shock Inspect the cord before use. Instrument tubing damage as a result of adhesive labels: The instrument tubing may break Do not attach adhesive labels or tape to the tubing. The use of unauthorized file systems: Unauthorized file systems can result in damage to the product and injury to persons. Only use authorized Ni-Ti file systems with a consistency >2%, suitable for rotary systems. Only use files with shafts meeting the requirements of ISO 1797-1, ISO 1797-2 and ISO 3630-1 and ISO 3630-2 norms, with a shaft diameter of 2.334 to 2.350 mm (0.092 to 0.093 inch). Please pay attention to the information provided by the manufacturer (method of operation, speed, torque stages, torsion consistency etc.) and appropriate use of the files. The use of damaged files: Damaged files can result in damage to the product and injury to persons. Before each root canal preparation, a rubber dam must be put in place for safety reasons. Each time before use, the files must be checked for possible signs of material fatigue, deformation or overstress and must be replaced if such signs are present. Endangering of the practitioner and the patient: Stop using the device immediately in the event of damage, irregular running noises, excessive vibrations, unusual generation of heat or if the drill bit is not firmly gripped. Page 5 E-STATIS Advantage 40

1 Important Information Torque too high: Damage of the attachment. Attachment for root canal treatments should only be used in the Endodontic mode. Note: Together with the dental treatment device, this medical device meets the requirements of IEC 60601-1-2. Only trained personnel are authorized by the manufacturer to repair and maintain the medical device. Any claim under warranty shall be excluded if defects or the consequences thereof are due to manipulation or modifications to the product by the customer or by any third parties not authorized by SciCan. Product Variant The E-STATIS Advantage kit is an update of SciCan's E-STATIS kit. All specifications of the E-STATIS Advantage are identical to the E-STATIS, except the motor, which is smaller and lighter than the motor which is packaged in the E-STATIS kit. Applied Symbols Appearing in the manual: A potential hazard to the operator. Important information Appearing on the unit: Type B applied part Operation mode: Duty cycle. The operation time is 0.5 minutes with a 9 minutes interval. Observe operator's manual! Disposal information see Important Information "Disposal" Date of manufacture / Manufacturer CE label VDE test mark CSA/UL test mark Appearing on the packaging: Fragile Stacking restrictions Humidity Keep dry Temperature range Quantity Transport upright Air pressure Manufacturer Exclusion of Liability Supply of spare parts, service and maintenance may only be carried out by authorized personnel. SciCan shall assume no liability for accidental, special or consequential damage caused by maintenance or service of the E-STATIS Advantage by third parties, or for use of equipment or parts manufactured by third parties, including loss of profit, any commercial loss, economic loss or loss incurred by personal injury. Never remove the cover of the device and never insert objects through the holes or openings on the case. Non-compliance may cause damage to the device and/or may endanger the user. Page 6 E-STATIS Advantage 40

2 Cleaning and Maintenance 2 Cleaning and Maintenance Cleaning and surface desinfection Use only disinfectants approved within the market of use. Disinfect with a clean, damp cloth using isopropyl alcohol - see illustration below. Do not exert any pressure on the LCD screen. Do not use products containing acetone, chlorine or bleach as disinfecting agents. Never immerse in solvent. Maintenance ATTENTION! Repair and maintenance work on the electrical part of the E-STATIS Advantage must be performed only by specialists or by persons trained in the factory and familiarized with the safety regulations. DO NOT OPEN THE CONTROL UNIT. There are no serviceable parts inside the control unit. Page 7 E-STATIS Advantage 40

3 Installation and Commissioning 3 Installation and Commissioning Operate the medical device exclusively with dental motor SciCan type E-STATIS SLM and power supply type AMM120PS36. Location Product installation can be on top, bottom or side of the dental unit in an accessible location. Mount power supply so, that seperation is easy to accomplish. Connection Damage as a result of incorrect pressures. Motor or instrument defect. Configure pressures in accordance with technical data! Damage as a result of poor quality media. Defect of motor or attachment. ISO 7494-2 states that compressed air must be clean, dry and free from oil. Note: If necessary, insert a filter, water trap or air dryer. Air requirements - see also: chapter 7 Specifications Measure cooling air quantity at motor coupling see also: chapter 3 Installation and Commissioning "Measure cooling air quantity at motor coupling" Connect Power Supply Note: The power supply must be connected in compliance with country specific regulations and requirements for medical devices. Connect the power supply cord to the back of the control unit. Connect the mains cable to the power supply. Connect the mains plug to mains. Page 8 E-STATIS Advantage 40

3 Installation and Commissioning Connect Control Unit Connect the 4-hole, 5-hole or 6-hole tubing (according ISO 9168) to the four-hole connection of the control unit. Connect Dental Motor Connect the dental motor with the motor tube. Measure the cooling air quantity of the motor coupling Attach a commercially available air quantity measurement tube to the motor. (Max. value of air outlet (e.g. 6 Nl/min), see manual of E-STATIS SLM motor, doc. no. 2.000.9473.) Page 9 E-STATIS Advantage 40

3 Installation and Commissioning Calibrate Foot Control Press "Set up" key. The display then goes in to set up mode. Pressing the button starts the "psi/bar" calibration process. Proceed as follows: 1. If "MAX" is not already displayed on the "PSI/BAR" button, press "PSI/BAR" once or twice until "MAX" appears displayed on the "PSI/BAR" button. 2. When "MAX" is displayed the unit is ready to activate calibrating the maximum pressure. 3. Press the foot control ALL THE WAY DOWN and keep holding it down. Press and HOLD "PSI/BAR" button, (while "MAX" is displayed and foot control is being held all the way down), until signal sounds. Maximum pressure has now been calibrated (to equal 100%). 100% 4. The "PSI/BAR" button should now have "MIN" displayed on it. If it does not, then press "PSI/BAR" once or twice until "MIN" appears displayed on the "PSI/BAR" button. 5. When "MIN" is displayed the unit is ready to activate calibrating the minimal pressure. 6. DO NOT PRESS THE FOOT CONTROL AT ALL Press and HOLD "PSI/BAR" button, (while "MIN" is displayed), until signal sounds. Minimum pressure has now been calibrated (to equal 0%). 0% Calibration is finished. Page 10 E-STATIS Advantage 40

4 Operation 4 Operation General Operation Parameters configured incorrectly Damage caused as a result of incorrect input values. Check all input values before use. In preparation mode, the motor speed or drill speeds are displayed according to the speed increase or reduction ratio. In Endodontic mode, the drill speed, torque and drill direction are shown on the display. Gearbox ratio incorrect Damage caused as a result of incorrect speed/torque. Select the corresponding transfer factor from the menu and store. Damage resulting from use of a non authorized power supply. Damage of product Only operate the medical device with the power supply supplied! Infection Control After treatment of a patient, let spray air and spray water leak for at least 20 seconds. Because of stagnation, water- or air-conveying lines in treatment units must be flushed or blown through before initial operation and after standing times (weekend, public holiday, vacation, etc.). The sterilization of the medical device must be effected via the treatment unit in the preparation mode. Demo Mode Never use Demo Mode for patient treatment. Switch on medical device Switch on product by plugging into the electrical circuit. The front circuit board and controller software versions are displayed on screen for a few seconds. For example: (V xx) OK* (V xx) ** * Software version display ** Software version control unit The parameters set (e.g. speed) are then shown on the display. Note: Once the foot control has been calibrated, the product is ready for use. Calibrate foot control - see also: chapter 3 Installation and Commissioning "Calibrate foot control" Start of the dental motor Note: The motor start pressure is 1 bar (14.5 psi). The minimum operating pressure at 40,000 rpm is 1.8 bar (26.1 psi). Page 11 E-STATIS Advantage 40

4 Operation Press down the foot control until the motor start pressure (1 bar / 14.5 psi) is exceeded. Motor started. Press the foot control fully down. The configured speed is reached. Page 12 E-STATIS Advantage 40

4 Operation Mode - Interpretation Preparation Mode Endodontic Mode Set-up Mode Page 13 E-STATIS Advantage 40

4 Operation Display Symbols The following menu options can be called up: Button Function Mode Set-up mode for submenu Entry and exit Instrument light on / off Submenu: illumination setting Submenu: illumination setting - delay time Calibration of foot control / working pressure Speaker (on / off) (Audio) Display contrast setting Main menu and Set-up menu Main menu and Set-up menu Submenu in the Set-up Submenu in the Set-up Submenu in the Set-up Submenu in the Set-up Change parameter values Submenu and main menu Change parameter values Submenu and main menu Direction of rotation counter-clockwise Direction of rotation clockwise with Auto Stop Direction of rotation Auto Reverse Direction of rotation Auto Reverse Forward Main menu Main menu E1 to E5 (Endodontic mode) Main menu E1 to E5 (Endodontic mode) Main menu E1 to E5 (Endodontic mode) Bur speed Main menu E1 to E5 and P1 to P3 Ratio setting of the low speed attachments Main menu E1 to E5 and P1 to P3 Page 14 E-STATIS Advantage 40

4 Operation Button Function Mode to (E1, E2, E3, E4, E5) Memory cell for Endodontic mode Main menu to (P1, P2, P3) Memory cell for preparation Main menu Torque value setting Main menu E1 to E5 Demonstration of motor rotation without air connection Touch-screen standby time: Screen shuts down into standby mode after chosen time of 0, 5, 10, 15 or 30 minutes. To turn back on, press foot control. Start motor Set-up menu Set-up Menu Demonstration mode Stop motor Demonstration mode Service menu - for service technician ONLY Set-up menu Factory settings Set-up menu Additional memory of reduction ratio for future handpieces with different ratios than currently available Set-up menu Settings: Preparation Mode P1 to P3 Factory settings: Key Ratio / reduction rate Speed Light P1 1 : 5 200,000 rpm on P2 1 : 1 40,000 rpm on P3 4 : 1 10,000 rpm on Possible settings: Ratio / reduction rate Direction of rotation (clockwise or counter-clockwise) Light on / off Page 15 E-STATIS Advantage 40

4 Operation Speed selection at ratio 1:1 Speed selection at ratio 4:1 up to 1,000 rpm : in steps of 50 up to 100 rpm : in steps of 5 up to 2,000 rpm : in steps of 100 up to 1,000 rpm : in steps of 50 up to 10,000 rpm : in steps of 500 up to 2,000 rpm : in steps of 100 up to 40,000 rpm : in steps of 1,000 up to 10,000 rpm : in steps of 500 Menu P1, P2, P3 Press the P1, P2 or P3 button (when activated, the button color changes). Activate the gear ratio by pressing the "GEAR RATIO" symbol. Select the appropriate increase or reduction ratio using the "+" or " " symbol. Confirm the gear ratio by pressing the "GEAR RATIO" symbol again. Activate the speed by pressing the "SPEED" symbol (when activated, the background color changes to light grey). Change the speed using the "+" or " " symbol until the speed you want appears in the display. Confirm by pressing the "SPEED" symbol again. The color changes to black. Select the fiber optic light by pressing the "LIGHT" symbol. If the symbol is black, the light is on; if the symbol is light grey, the light is off. Select the direction of rotation by pressing the "DIRECTION OF ROTATION" symbol. If the symbol is white, the direction of rotation is clockwise; if the symbol is light grey, the direction of rotation is counter-clockwise. Pressing the "P1" button and holding it in until the signal sounds stores the options set in menu option P1. Follow the same procedure for setting P2 and P3, if desired. Settings: Endodontic Mode E1 to E5 Factory settings: Key Ratio / reduction rate Speed Torque Direction of rotation light E1 4 : 1 400 rpm 0.4 Ncm Auto Reverse on E2 4 : 1 400 rpm 0.4 Ncm Auto Reverse on E3 4 : 1 400 rpm 0.4 Ncm Auto Reverse on E4 4 : 1 400 rpm 0.4 Ncm Auto Reverse on E5 4 : 1 400 rpm 0.4 Ncm Auto Reverse on Possible settings: Ratio / reduction rate Direction of rotation (Auto Stop, Auto Reverse, Auto Reverse Forward) Torque limit Ncm Speed selection Light on / off Menu E1, E2, E3, E4, E5 Note: The spray air and spray water must be switched OFF at the dentist element / foot control. Page 16 E-STATIS Advantage 40

4 Operation Procedure with selecting E1 (Endodontic Mode): Press the "E1" button (when activated, the background color changes to light grey). Activate the gear ratio by pressing the "GEAR RATIO" symbol. Select the appropriate increase or reduction ratio using the "+" or " " symbol. Confirm the gear ratio by pressing the "GEAR RATIO" symbol again. Activate the speed by pressing the "SPEED/RPM" symbol (when activated, the background color changes to light grey). Change the speed using the "+" or "-" symbol until the speed you want appears in the display. Confirm the speed by pressing the "SPEED/RPM" symbol again. The color changes to black. Select the torque by pressing the "TORQUE" symbol. The light grey symbol shows the active status. Select the appropriate torque value using the "+" or " " symbol. Confirm by pressing the "TORQUE Ncm" symbol again. Select the fiber optic light by pressing the "LIGHT" symbol. If the symbol is black, the light is on; if the symbol is light grey, the light is off. Select the direction of rotation by pressing the "DIRECTION OF ROTATION" button until the button for the desired direction is displayed. The choices will be: AUTO STOP, AUTO REVERSE or AUTO REVERSE FORWARD Note: The torque value determines the point at which the direction of rotation will stop in "AUTO STOP"; and the point at which the direction of rotation will reverse when in "AUTO REVERSE" and in "AUTO REVERSE FORWARD". Confirm the direction of rotation by pressing and holding the "DIRECTION OF ROTATION" button. Pressing the "E1" button and holding it in until the signal sounds stores the options set in menu option E1. Follow the same procedure for setting E2 through E5, if desired. Settings: Set-up Menu Press the "RETURN" button changes the display in set-up mode. The following parameters can be set here: Calibration (see: chapter 3 Installation and Commissioning "Calibrate foot control") Parameters Setting options Factory setting Speaker on / off on Illumination 1-10 5 Fiber Optic Delay 1-5 s 2 Display contrast more / less zero setting Reverse time of Auto Reverse Forward 1-5 sec. 2 sec. Page 17 E-STATIS Advantage 40

4 Operation Pressing the "SPEAKER" button changes the operating status of the speaker. If the symbol is white, the speaker is on; if the symbol is light grey, the speaker is off. By pressing the "ILLUMINATION" symbol, a number appears next to the symbol. This number can be changed by using "+" or " ". The number 1 equals the lowest light output, the number 9 is the maximum light output. Confirm the illumination setting by pressing the "ILLUMINATION" symbol again. The set and stored value appears next to the symbol. By pressing the "FIBER OPTIC DELAY" symbol, the delay time can be changed by using "+" or " ". Choose from 1 second to 5 seconds (delay time). Confirm the fiber optic delay time by pressing the "FIBER OPTIC DELAY" symbol again. The set and stored value appears next to the symbol. By pressing the "AUTO REVERSE FORWARD" symbol, a number with "t" appears next to the symbol. The number can be changed by using "+" or " ". 1 second to 5 second delay time for Auto Reverse Forward. Confirm the delay time set by pressing the "AUTO REVERSE FORWARD" symbol again. The set and stored value appears next to the symbol. Pressing the "DISPLAY CONTRAST" button activates the symbol. The display contrast can be changed by using "+" or " ". Confirm the contrast set by pressing the "DISPLAY CONTRAST" button again. Select demo mode by pressing the "DEMO MODE" button. The display changes to the E1 display. The "START" button appears on the display. Press "START" button - the motor starts running for 2 minutes max. The running cycle of the motor can be interrupted by pressing "STOP" button. By pressing the "RETURN" button the set-up menu appears and the demo program is finished. Press the "RETURN" button, and the main menu appears. Standby time setting of the touch screen. Press "STANDBY" button. With "+" or " " select time. By pressing "STANDBY" button again the selected time is activated. All manual settings could be reactivated to the factory settings by pressing the "FACT SET" button. ATTENTION: All manual settings will be cancelled when this button is pressed. Back to the main menu by pressing "RETURN" button. Press one of the "ADDITIONAL MEMORY" buttons (button number 1 or button number 2). With "+" or " " select the desired transmission ratio. Confirm the ratio by pressing the "ADDITIONAL MEMORY" button again Page 18 E-STATIS Advantage 40

5 Troubleshooting 5 Troubleshooting The medical device heats up and gets excessively hot when running without a load: Check the amount of cooling air. The medical device has no lighting: Lighting control not activated - check symbol on the control unit. Phase interrupted (Error code "ERR 10"): Check the connection. Motor not correct connected (Error code "ERR 10"): Check the connection. Position sensor not connected (Error code "ERR 82"): Check the connection. Phase short circuit (Error code "ERR 84"): Tube or motor defective. Repair needed. Motor or attachment defects: Incorrect pressure - Configure pressure in accordance with technical specifications. Poor quality air or water supply - check symbols on the control unit. Note: If necessary, insert a filter, water trap or air dryer. Air requirements - see also: chapter 7 Specifications Page 19 E-STATIS Advantage 40

6 Information on Electromagnetic Compatibility 6 Information on Electromagnetic Compatibility The medical device is suitable for use in the specified electromagnetic environment. The purchaser or user of the medical device should ensure that it is used in an electromagnetic environment as described below: Emission Test Compliance Electromagnetic Environment Radio-Frequency Emissions CISPR 11 Group 1 The medical device uses RF energy only for its internal function. Therefore, the RF emission is very low and not likely to cause any interference in nearby electronic equipment. Radio-Frequency Emissions CISPR 11 Class B The medical device is for use in all facilities including residential facilities Harmonic emissions IEC 61000-3-2 Voltage fluctuations / flicker emissions IEC 61000-3-3 Class A Complies and facilities that are directly connected to a public power supply that also supplies residential buildings. Immunity tests IEC 60601-test level Conformance level Electromagnetic environment - guidelines Electrostatic discharge (ESD) IEC 61000-4-2 Fast transient electrical disturbances/ Bursts IEC 61000-4-4 Surges IEC 61000-4-5 Voltage interruptions, short-term interruptions and fluctuations of the supply voltage IEC 61000-4-11 Magnetic field with a supply frequency (50/60 Hz) per IEC 61000-4-8 Conducted HF disturbances IEC 61000-4-6 Radiated HF disturbances IEC 61000-4-3 ± 6 kv contact discharge ± 8 kv atmospheric discharge ± 2 kv for power lines ± 1 kv for signal lines ± 1 kv push-pull voltage ± 2 kv common mode voltage <5% U T for 0.5 periods 40% U T for 5 periods 70% U T for 25 periods <5% U T for 250 periods ± 6 kv contact discharge ± 8 kv atmospheric discharge ± 2 kv for power lines ± 1 kv for signal lines ± 1 kv push-pull voltage ± 2 kv common mode voltage <5% U T for 0.5 periods 40% U T for 5 periods 70% U T for 25 periods <5% U T for 250 periods Floors should be made of wood or concrete or have ceramic tiles. When the floor is covered with synthetic material, the relative humidity must be at least 30%. The quality of the supply voltage should correspond to that of a typical business or hospital environment. The quality of the supply voltage should correspond to that of a typical business or hospital environment. The quality of the supply voltage should correspond to that of a typical business or hospital environment. When the user of the medical device needs continued operation even when the power supply is interrupted, it is recommended to supply the medical device from an uninterrupted power supply or a battery. 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial hospital. 3 V eff 150 khz to 80 MHz outside of the ISM bands a 3 V/m 80 MHz to 2.5 GHz 10 V eff Portable and mobile radio devices should not be used closer to the medical device (including the electrical lines) than the recommenced safe distance calculated using the equation for the transmission frequency. Recommended 10 V/m safe distance: d = 0.50 P d = 0.35 P for 80 MHz to 800 MHz d = 0.70 P for 800 MHz to 2.5 GHz with P as the maximum rated power of the transmitter in Watts (W) according to the transmitter manufacturer, and d as the recommended safe distance in meters (m). b The field strength of stationary radio transmitters should be less than the conformance level at all frequencies in an onsite check c. d Disturbances are possible close to devices that have the following symbol. Page 20 E-STATIS Advantage 40

6 Information on Electromagnetic Compatibility NOTE: U T is the alternating mains voltage before the test level is used. NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not be applicable in every case. The spread of electromagnetic waves is absorbed and reflected by buildings, objects and people. a The ISM frequency bands (for industrial, scientific and medical applications) between 150 khz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHZ to 27.283 MHz and 40.66 MHz to 40.70 MHz. b The conformance levels in the ISM frequency bands between 150 khz and 80 MHz and the frequency range of 80 MHz and 2.5 GHz are intended to reduce the probability that mobile and portable communications equipment will produce disturbances when they are unintentionally brought near the patient. For this reason, the additional factor of 10/3 is used when calculating the recommended safe distances within these frequency ranges. c The field strength of stationary transmitters such as base stations of mobile telephones and land mobile radio devices, amateur radio stations, AM and FM, radio and television broadcasters cannot be theoretically predetermined. To determine the electromagnetic environment of stationary transmitters, a study of the location should be considered. When the measured field strength at the site where the medical device is used exceeds the above conformance level, the medical device should be monitored to demonstrate proper function. When unusual performance features are observed, additional measures may be necessary such as realigning or moving the medical device. d Within the frequency range of 150 khz to 80 MHz, the field strength should be less than 3 V eff V/m. Recommended safe distance between portable and mobile HF telecommunications equipment and the medical device. The medical device is intended for use in an electromagnetic environment in which HF disturbances are controlled. The customer or the user of the medical device can help prevent electromagnetic disturbances by maintaining the minimum distance between portable and mobile HF telecommunications devices (transmitters) and the medical device depending on the output of the communication device as indicated below. Rated power of the transmitter / W Safe distance depending on the transmission frequency / m 150 khz to 80 MHz d=0.35 P 80 MHz to 800 MHz d=0.35 P 800 MHz to 2.5 GHz d=0.70 P 0.01 0.04 0.04 0.07 0.1 0.11 0.11 0.22 1 0.35 0.35 0.70 10 1.11 1.11 2.21 100 3.50 3.50 7.00 For transmitters whose maximum rated power is not in the above table, the recommended safe distance d in meters (m) can be calculated using the equation for the respective gap, where P is the maximum rated power of the transmitter in Watts (W) according to the manufacturer's information. NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not be applicable in every case. The spread of electromagnetic waves is absorbed and reflected by buildings, objects and people. Page 21 E-STATIS Advantage 40

7 Specifications 7 Specifications Control Unit Motor speed range (forward / reverse): 100 40,000 rpm Output torque: max. 3.0 Ncm Motor current: max. 5.7 A / Phase Motor voltage: max. 22 V AC Operation mode: Duty cycle (0.5 on / 9 off) minutes Current of LED: max. 250 ma Weight: 0.69 (1.521) kg (lbs) Dimensions (Width/Height/Depth): 110 x 76 x 175 (4.33 x 2.99 x 6.89) mm (inch) Rotation: clockwise / counter-clockwise Sound level: < 40 dba Instrument connection: ISO 3964 Protection class: Part of class I system Overvoltage category: II Pollution degree: P2 Device classification of applied part (EN 60601): Type B Protection category: IP 20 Power Supply Rated voltage: 100 240 V AC Rated frequency: 50 / 60 Hz Power consumption: 120 VA Operation mode: Duty cycle (0.5 on / 9 off) minutes Weight: 0.57 (1.26) kg (lbs) Dimensions (Width/Height/Depth): 73 x 41 x 175 (2.87 x 1.61 x 6.89) mm (inch) Protection class: I Overvoltage category: II Pollution degree: P2 Protection category: IP 40 Media Supply Data to Control Unit System pressure: 1.8 4.0 (26 58) bar (psi) Spray air: 1.0 2.5 (14.5 36.2) bar (psi) Spray water: 0.8 2.0 (11.6 29) bar (psi) Air requirements: Dry, free from oil, clean, uncontaminated according ISO 7494-2 Air filter: 50 µm Water quality: Tap water ph-value: 7.2 7.8 Water filtration provided by customer: 80 µm Page 22 E-STATIS Advantage 40

7 Specifications Recommended Settings System pressure: Spray air: Spray water: 3.0 (43.5) bar (psi) 1.0 (14.5) bar (psi) 0.8 (11.6) bar (psi) Ambient Conditions Location: Permitted in interior rooms Ambient temperature: 10 40 (50 104) C ( F) Relative humidity: 30 75 % Max. altitude: 2,000 m Storage and Transport Conditions Danger when start-up the medical device after storage in very cold conditions. This can cause an operational failure of the medical device. Very cold devices must be brought to a temperature of 20 25 C (68 77 F) before being started up. Ambient temperature: -30 to 70 (-22 to 158) C ( F) Relative humidity: 5 95 % Air pressure: 700 1,060 hpa Keep dry! We reserve the right to make technical modifications. Type Label The explanations of the symbols are described in chapter 1 Important Information Page 23 E-STATIS Advantage 40

8 Spare Parts 8 Spare Parts Spare Parts Page 24 E-STATIS Advantage 40

9 Guarantee 9 Guarantee Limited Warranty For a period of three years, SciCan guarantees that the E-STATIS Advantage, when manufactured by SciCan in new and unused condition, will not fail during normal service due to defects in material and workmanship that are not due to apparent abuse, misuse, or accident. The three years warranty will cover the performance of all components of the unit except consumables, provided that the product is being used and maintained according to the description in the operator's manual. In the event of failure due to such defects during this period of time, the exclusive remedies shall be repair or replacement, at SciCan's option and without charge, of any defected part(s) (except gaskets, seals, O-rings and couplings), provided SciCan is notified in writing within thirty (30) days of the date of such a failure and further provided that the defective part(s) are returned to SciCan prepaid. This warranty shall be considered to be validated, if the product is accompanied by the original purchase invoice from the authorized SciCan dealer, and such invoice identifies the item by serial number and clearly states the date of purchase. No other validation is acceptable. After three years, all SciCan warranties and other duties with respect to the quality of the product shall be conclusively presumed to have been satisfied. All liability, therefore, terminate, and no action or breach of any such warranty or duty may thereafter be commenced against SciCan. Any express warranty not provided hereon and any implied warranty or representation as to performance, and any remedy for breach of contract which, but for this provision, might arise by implication, operation of law, custom of trade or course of dealing, including any implied warranty of merchantability or of fitness for particular purpose with respect to all and any products manufactured by SciCan is excluded and disclaimed by SciCan. If you would like to learn more about SciCan products and features, visit our website at www.scican.com. Operating instructions in other languages are available on SciCan's website: www.scican.com Page 25 E-STATIS Advantage 40

E-STATIS Advantage 40 System / Système Manuel de l opérateur www.scican.com E-STATIS Advantage 40

Table des matières fr 1 Informations importantes... 28 Liste du contenu... 28 Usages prévus... 28 Destruction... 29 Révisions... 29 Mode de fonctionnement... 29 Mesures de sécurité... 29 Symboles utilisés... 31 Exclusion de responsabilité... 31 2 Nettoyage et maintenance... 32 Nettoyage...Fehler! Textmarke nicht definiert. Maintenance... 32 3 Installation et mise en service... 33 Lieu d'installation... 33 Branchement... 33 Raccordement de l alimentation électrique... 33 Branchement du boîtier de commande... 34 Branchement du moteur dentaire... 34 Calibration de la pédale... 35 4 Fonctionnement... 36 Fonctionnement général... 36 Modes : Interprétation... 38 Symboles apparaissant à l écran... 39 Paramètres : Mode Préparation, touches P1 à P3... 40 Paramètres : Mode Endodontique, touches E1 à E5... 41 Paramètres : Menu de Paramétrage... 42 5 Conseils de dépannage... 44 6 Informations sur les émissions électromagnétiques... 45 7 Spécifications... 47 Boîtier de commande... 47 Bloc d'alimentation... 47 Données relatives à l alimentation des supports reliés le boîtier de commande... 47 Recommandations de paramétrages... 48 Conditions ambiantes... 48 Plaque signalétique... 48 8 Pièces de rechange... 49 9 Garantie... 50 E-STATIS est une marque de SciCan Ltd. Toutes les autres marques mentionnées dans le présent manuel sont la propriété de leurs titulaires respectifs. SciCan Ltd. 1440 Don Mills Road Toronto, ON M3B 3P9, CANADA Tél. : +1-416-445-1600 Fax : +1-416-445-2727 Appel gratuit : +1-800-667-7733 E-mail: SciCan Medtech AG Fabriqué par : Alpenstrasse 16 6300 Zug, SUISSE SciCan GmbH Tél. : +41-41-727-70-27 Wangener Strasse 78 Fax : +41-41-727-70-29 techservice.ca@scican.com 88299 Leutkirch SciCan Inc. ALLEMAGNE 701 Technology Drive Tél. : +49-7561-98343-0 Canonsburg, PA 15317, USA Fax : +49-7561-98343-699 0297 Tél. : +1-724-820-1600 Fax : +1-724-820-1479 E-STATIS Advantage 40

1 Informations importantes 1 Informations importantes Cher utilisateur, Nous espérons que votre produit vous donnera entière satisfaction. Pour éviter tout dysfonctionnement ou risque lors de l utilisation du produit, veuillez respecter scrupuleusement les instructions fournies ci-après. Liste du contenu : Appareil E-STATIS Advantage Moteur E-STATIS SLM Manuel de l opérateur Alimentation électrique 100 240 V AC Câble d alimentation électrique La notice d utilisation doit être lue par l utilisateur avant la première mise en route de l appareil afin d éviter toute utilisation incorrecte ou détérioration. La reproduction et / ou la distribution de la présente notice d utilisation sont subordonnées au consentement préalable du fabricant. Toutes les spécifications, informations et propriétés du produit décrites dans la présente notice d utilisation correspondent au statut du produit au moment de l impression de ladite notice. Des modifications et améliorations du produit suite à de nouveaux progrès techniques sont possibles. Cela n'implique aucun droit à une éventuelle mise à niveau des unités existantes. Le fabricant décline toute responsabilité pour les dommages causés par : Des influences externes (mauvaise qualité des supports ou installation incorrecte) L'utilisation d'informations erronées Une utilisation incorrecte Des réparations effectuées de façon incorrecte. Les réparations et interventions de maintenance (autres que les actions décrites dans ce manuel) doivent exclusivement être réalisées par un personnel technique qualifié. Si des modifications sont apportées par des tierces parties, les licences existantes du dispositif médical peuvent être annulées. Seules des pièces et pièces de rechange d'origine doivent être utilisées. Usages prévus Ce dispositif médical : n est destiné qu aux traitements dentaires. Tout autre usage ou altération du produit est interdit et peut être dangereux. est destiné aux utilisations suivantes : Suppression d éléments et de cavités cariés et préparation de couronnes, suppression de plombages et de surfaces de restauration, traitement endodontique. est un dispositif médical conformément à la réglementation nationale applicable. Ce produit médical : comporte un moteur électrique à basse tension pour application dentaire de Type 2 conforme à la norme ISO 11498. Ne doit pas être utilisé dans les zones à fort risque d'explosion. (L utilisation de l unité de traitement dentaire n est pas compatible avec une atmosphère présentant un mélange de substances inflammables. Définition (application recherchée) Signification Fonction principale Traitement dentaire pour préparation et soins endodontiques. Usage Destiné au traitement dentaire des couronnes et des racines Principales spécifications de fonctionnement Composant supplémentaire pour appareil de soin dentaire avec alimentation sur secteur. Durée d utilisation Env. 30 à 40 minutes par jour avec interruptions intermédiaires. Population : Tous les patients (toutes catégories d âge) Page 28 E-STATIS Advantage 40

1 Informations importantes En vertu de ces dispositions, la turbine ne doit être manipulée que par un utilisateur expérimenté dans le cadre de l'application décrite, conformément à : La réglementation applicable en matière de santé et de sécurité La réglementation applicable sur la prévention des accidents La notice d'utilisation En vertu de ces réglementations, l'utilisateur est tenu de : N'utiliser que des outils exempts de défauts et fonctionnant correctement N utiliser que des outils adaptés à l application recherchée Se protéger et protéger le patient et les tierces parties contre tout danger Éviter toute contamination émanant du produit Manipulation inadéquate des embouts à main : Une manipulation érronée peut occasionner des blessures sur autrui. Veuillez suivre le mode d emploi fourni à part pour les accessoires. Groupe cible : Le présent document est destiné aux dentistes et au personnel des cabinets dentaires. Destruction Consommables : Les rebuts générés devront être recyclés ou détruits d une manière non préjudiciable aux être humains et à l environnement ; lors de ce processus, les réglementations nationales en vigueur devront être respectées. Destruction des outils et accessoires en fin de vie utile : En vertu de la Directive CE (2002/96/CE) relative aux déchets d équipements électriques et électroniques, nous signalons que le présent produit est soumis à ladite directive et que son élimination en Europe doit s effectuer selon une procédure spéciale. Des informations complémentaires peuvent être obtenues auprès du fabricant ou de votre fournisseur de matériel dentaire. Révisions Remarque : Envoyer le produit en révision tous les 2 ans. Le contrôle de sécurité (STK) régi par la norme VDE 0751-1 et le contrôle d exactitude des mesures (MTK) seront réalisés au cours de cette révision. Les contrôles de sécurité peuvent varier d un pays à l autre conformément aux réglementations et aux exigences spécifiques à chaque Etat en matière de dispositifs médicaux. Les réglementations nationales en vigueur doivent être respectées. Mode de fonctionnement Remarque : Une durée de fonctionnement de 30 secondes à 9 minutes d'intervalle entre chaque utilisation représente la charge limite admissible du moteur (à pleine charge et à vitesse maximale). Dans la pratique, la durée d impulsion à la charge peut raisonnablement durer plusieurs secondes et les intervalles, un laps de temps situé entre plusieurs secondes et plusieurs minutes, sans pour autant que le courant électrique du moteur atteigne de manière habituelle son niveau maximal. Cela correspond à la procédure habituelle dans la pratique des dentistes. Mesures de sécurité Risques liés aux champs magnétiques (stimulateurs cardiaques ou pacemakers) Le fonctionnement des systèmes implantables (tels que les stimulateurs cardiaques) peut être perturbé par les champs électromagnétiques. Interrogez vos patients à ce sujet préalablement au traitement et informez-les des risques. Page 29 E-STATIS Advantage 40

1 Informations importantes Électricité : Choc électrique provoqué par le branchement inadéquat d un outil tiers au dispositif médical. Lors de l installation et de la mise en route du dispositif médical à l aide d outils et de dispositifs provenant d un autre fabricant, veuillez observer les dispositions énoncées dans la section «Protection contre les risques de chocs électriques,» «Courants de fuite» et «Pas de mise à la terre de la partie en application sur le patient» conformément à la norme CEI 60601-1. Risques liés à une insuffisance d outils de contrôle : Des dangers peuvent survenir dans les cas où des outils de contrôle ne sont pas à disposition de l utilisateur pour modifier la vitesse ou le sens de rotation Une fois branché, l appareil de traitement dentaire doit être doté de commandes directes permettant de modifier la vitesse et le sens de rotation. De plus, les documents fournis avec l appareil doivent mentionner ces outils en raison des responsabilités afférentes à l innocuité, à la fiabilité et à la performance de l'appareil. Usure prématurée et dysfonctionnements causés par un défaut d entretien ou de maintenance : Risque de réduction de la durée de vie du produit : Procéder régulièrement aux opérations d'entretien et de maintenance appropriées. Dysfonctionnements liés à des champs électromagnétiques : Le produit est conforme aux exigences applicables concernant les champs électromagnétiques. Étant données les interactions complexes entre ce matériel et les téléphones portables, l utilisation d un téléphone portable peut perturber le fonctionnement du produit. Ne pas utiliser de téléphone portable dans les cabinets médicaux, hôpitaux ou laboratoires. Éteindre les dispositifs électroniques tels que les supports de stockage informatique, prothèses auditives, etc. pendant l utilisation du produit. Câble secteur endommagé / câble secteur fragilisé / absence de câble de garde Choc électrique Inspecter le câble secteur avant utilisation. Détérioration du cordon de l instrument suite à l utilisation d étiquettes autocollantes : Le cordon de l instrument peut se rompre. Ne pas apposer d étiquettes autocollantes ni de ruban adhésif sur le cordon. L utilisation de systèmes de limage non autorisés : L utilisation de systèmes de limage non autorisés peut occasionner la détérioration du produit ou des blessures à l encontre d autrui. N utiliser que des systèmes de limes Ni-Ti autorisés de conicité supérieure à 2%, compatibles avec les appareils rotatifs. N utiliser que des limes équipées de tiges conformes aux exigences des normes ISO 1797-1, 1797-2 et ISO 1797-3 et ISO 3630-2, d un diamètre de tige de 2,334 à 2,350mm (0,092 à 0,093 pouces). Veuillez lire attentivement les informations fournies par le fabricant (mode opératoire, vitesse, valeurs de couple, résistance à la torsion, etc.) et utiliser les tiges adéquates. L utilisation de tiges endommagées : L utilisation de systèmes de limage non autorisés peut occasionner la détérioration du produit ou des blessures à l encontre d autrui. Préalablement à chaque préparation d un canal radiculaire, une digue en caoutchouc doit être mise en place pour des raisons de sécurité. A chaque utilisation, préalablement à l opération, les tiges doivent être examinées pour repérer des signes probables de fatigue matérielle, de déformation ou de tension excessive ; elles doivent être remplacées en cas de présence de signes de cette nature. Mise en danger du praticien et du patient : Interrompre immédiatement l utilisation de l'appareil si celui-ci est endommagé, qu'il émet des bruits irréguliers en fonctionnement, qu'il produit des vibrations excessives, qu'il émet une chaleur inhabituelle ou si le foret n'est pas fermement enclenché. Page 30 E-STATIS Advantage 40

1 Informations importantes Couple trop puissant : Endommagement de l accessoire. L accessoire destiné au traitement du canal radiculaire ne doit être utilisée qu en mode Endodontic. Remarque : Conjointement au dispositif de traitement dentaire, cet accessoire est conforme aux exigences de la norme 60601-1-2. Seul un personnel qualifié est autorisé par le fabricant à effectuer la réparation et l entretien du dispositif médical. Aucune réclamation en vertu de la garantie ne sera admise si les défauts ou les conséquences de ceux-ci sont dus à une manipulation ou des modifications du produit par le client ou par toute tierce partie non autorisée par SciCan. Variantes du produit L appareil E-STATIS Advantage est une version remise à niveau de l appareil E-STATIS de SciCan. Toutes les spécifications de l E-STATIS Advantage sont identiques à celles de l E-STATIS, à l exception du moteur, plus petit et plus léger que le moteur fourni avec l E-STATIS. Symboles utilisés Dans le manuel : Sur l appareil / sur le moteur : Danger potentiel pour l utilisateur. Informations importantes Partie appliquée de type B Mode de fonctionnement : Service intermittent : la durée de fonctionnement est de 0,5 minutes avec des intervalles de 9 minutes. Remarque : consulter le manuel d instructions Remarque concernant la destruction, cf. Informations importantes, «Destruction des déchets» Date de fabrication / fabricant Marquage CE Label de contrôle VDE Label de contrôle CSA/UL Sur l'emballage : Fragile Conserver à l'abri de l'humidité Transporter en position verticale Restrictions d'empilement Plage de température Pression de l'air Humidité Quantité Fabricant Exclusion de responsabilité L envoi de pièces de rechange et la maintenance ne peuvent être effectués que par du personnel autorisé. SciCan décline toute responsabilité pour des dommages fortuits, extraordinaires ou dérivés qui résulteraient de réparations ou d opérations de maintenance de l E-STATIS Advantage effectuées par des tiers, ou qui seraient dus à l utilisation d équipements ou de pièces de rechange fabriqués par des tiers, y compris les manques à gagner de toute nature, les pertes commerciales, économiques ou résultant de blessures corporelles. Ne retirez jamais le capot de l appareil et n introduisez aucun objet dans les orifices du boîtier. La non-observation de cette précaution risque d endommager l appareil et/ou de mettre en danger l utilisateur. Page 31 E-STATIS Advantage 40